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What is aligned elements?

Aligned offers an integrated eQMS and design control for medical device and IVD organizations. The solution is engineered to help companies satisfy international regulatory expectations in a structured and efficient way, without adding unnecessary operational burden. The software aligns with major regulatory frameworks such as ISO 13485, FDA QSMR, EU MDR, and IVDR. It is used by professional teams who need reliable oversight of quality activities, product development, and regulatory documentation throughout the full lifecycle of their products. By uniting electronic quality processes and design control in one system, Aligned enables seamless collaboration across quality assurance, regulatory affairs, research and development, and executive functions. Product requirements, design records, verification and validation evidence, risk management activities, and controlled changes are inherently connected, providing continuous traceability and defensible documentation during audits and inspections.

What is IBM Engineering Lifecycle Management?

IBM Engineering Lifecycle Management (ELM) stands out as a state-of-the-art, comprehensive engineering solution, adeptly steering users through all phases, from gathering requirements to systems design, managing workflows, and overseeing testing, while simultaneously augmenting the functionality of ALM tools to cater to complex systems development. By adopting a comprehensive viewpoint throughout the product lifecycle and creating a solid digital framework for data traceability, organizations can effectively track changes, which helps in minimizing risks and reducing costs. Addressing the complexities of engineering from initial concepts to final implementation fosters team collaboration through a unified digital thread, encourages the use of modeling and reuse techniques, leverages insights from automated reporting, and enables scalable operations that lay a strong groundwork for ongoing innovation. The interconnected data within this digital thread will serve as a central source of truth, enabling various engineering fields—functional, software, mechanical, and electrical—to collaborate seamlessly. Such a cohesive methodology not only simplifies processes but also significantly boosts the overall efficiency and effectiveness of the engineering lifecycle, ultimately leading to superior project outcomes.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Planview Hub
Redmine

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Planview Hub
Redmine

API Availability

Has API

API Availability

Has API

Pricing Information

€1300 per year
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

IBM

Date Founded

1911

Company Location

United States

Company Website

www.ibm.com/products/engineering-lifecycle-management

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Requirements Management

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Product Management

Collaboration
Feedback Collection
Idea Management
Milestone Tracking
Prioritization
Product Roadmapping
Release Management
Requirements Management
Resource Management
Workflow Management

Requirements Management

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

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